Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-25 @ 9:07 PM
Study NCT ID:
NCT02899468
Status:
COMPLETED
Last Update Posted:
2018-04-27
First Post:
2016-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Novel Integrative and Intensive Virtual Rehabilitation Program for Service Members Post TBI
Sponsor:
Henry M. Jackson Foundation for the Advancement of Military Medicine
Organization:
Study Overview
Official Title:
Evaluation of a Novel Integrative and Intensive Virtual Rehabilitation Program for Service Members Post TBI
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the feasibility and effectiveness of a novel virtual reality (VR) therapeutic rehabilitative device (BrightBrainerTM) to treat patients with traumatic brain injury (TBI). These patients, service members with TBI, can be both with and without upper limb dysfunction and use uni- and bimanual virtual reality (VR) exercises to improve cognitive and motor function, as well as mood.
Detailed Description:
Bright Cloud International Corp created BrightBrainer, a computerized virtual reality system that provides a combination of cognitive as well as motor skill training in an engaging and repetitive manner \[1\]. This project objective is to assess the feasibility and clinical benefit of utilizing the BBVR to augment the rehabilitation of service members with TBI. The BrightBrainerTM Virtual Reality (BBVR) Rehabilitation System is unique because it is designed to provide integrative, customized, intensive and self-guided therapy that simultaneously addresses the cognitive, emotive and motor deficits. Early evidence suggests that it has been effective for patients with cognitive deficits as the result of cerebrovascular accident or dementia, but has not yet been evaluated in a therapeutic intervention for patients with TBI. In addition to assessing the system's effect on patient's symptoms, we will also evaluate the feasibility of utilizing this system in a military environment by obtaining feedback from the patients and therapists, regarding system acceptance, reliability and ease of use.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: